(24 days)
The LOSPA IS Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudarthrosis. or revision of failed fusion attempts.
LOSPA IS Spinal System cleared under K092076 is modified for inclusion of 5.5 diameter rods. The rod link (type -B) & pedicle screws are also modified to include 5.5 diameter rods. The rods are available in straight and pre bent configurations for optimal anatomical adjustment. The rod ends are either flat or bullet nosed. The bullet nose might eases navigation through soft tissue. The subject and predicate devices are similar in design, material, specification and manufacturing and are not altered and remain the same as discussed in K092076. Only the prebent rod is additionally available in CoCrMo alloy. The set screw used in the pedicle screw in is the same as approved in K092076, made up of Ti alloy (ASTM F 136) and can be used with both 5.5 mm and 6.0 mm rod system.
The LOSPA IS spinal system is this submission comprises of the following components,
- A. Pedicle Screws (Monoaxial & Polyaxial), standard and guided types, with screw diameters from 4.0 mm to 8.5 mm and length ranging from 20 mm to 55 mm. made up of Titanium Alloy (ASTM F 136).
- B. Straight Rods of diameter of 5.5 mm (Standard) made up of Titanium Alloy (ASTM F 136).
- C. Prebent Rods of diameter 5.5 mm (Standard & Bullet types) made up of Titanium . Alloy (ASTM F 136) & CoCr (ASTM F 1537)
- D. Rod link 5.5 (Type B) made up of Titanium Alloy (ASTM F 136).
All the components are manufactured from medical grade titanium alloy (ASTM F 136) & CoCrMo alloy (ASTM F 1537).
The provided text describes the Corentec Co., Ltd. LOSPA IS Spinal System (K132644), which is a pedicle screw spinal system.
Here's an analysis based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Testing | Performed similar or better than comparable predicate devices. |
| Dynamic Testing | Performed similar or better than comparable predicate devices. |
| International Standards Compliance | Testing conducted as per ASTM F1717 & ASTM F1798. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Corentec's LOSPA IS Spinal System modified components were subjected to a series of testing protocols." However, it does not specify the sample size for these tests (e.g., number of components tested for static or dynamic properties). The tests are described as being conducted on the modified components of the device itself, not on patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is a device performance study, not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a device performance study involving mechanical testing against international standards, not a study evaluating expert interpretation or diagnosis.
4. Adjudication Method for the Test Set:
Not applicable. The "test set" refers to the device components undergoing mechanical testing, not a set of clinical cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes mechanical performance testing of the device components, not a clinical study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This device is a spinal implant system, not an algorithm or AI. The study presented is a mechanical performance study.
7. Type of Ground Truth Used:
The ground truth for the device performance was established through international standards (ASTM F1717 & ASTM F1798). The device's performance was measured against the requirements and methodologies outlined in these standards, and its results were compared to predicate devices that also presumably met these standards.
8. Sample Size for the Training Set:
Not applicable. This is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a mechanical device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.